FDA Rejects Alimera Eye Implant, Again

October 18, 2013

(Reuters) - Alimera Sciences Inc said U.S. health regulators rejected for a third time its eye implant device Iluvien due to safety concerns.

Iluvien is a sustained-release implant used to treat vision impairment associated with chronic diabetic macular edema.

Iluvien has been approved by some European regulators, but the U.S. Food and Drug Administration has rejected it three times in the past three years.

The FDA raised concerns about the eye implant's safety profile in its complete response letter rejecting marketing approval, the company said on Friday.

The FDA also referred to deficiencies at the facility where Iluvien is manufactured, Alimera said.

Alimera said it did not believe that these deficiencies will affect its European commercial supply.

The FDA suggested at least 12 months of follow-up for all enrolled patients in a new trial and a meeting with the regulator's advisory panel to address the deficiencies.

The panel would advise whether a patient population can be identified in which the benefits of the drug might outweigh the risks, the FDA said. The panel will convene on Jan. 27.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.